Category Archives: Health Care Providers

Two months in and this year has already seen significant movement in regulatory action across the country to expand the ability to provide telemedicine services. Below please find some of the more significant items that have already gone into effect in 2016 or are under consideration, including commercial payor and Medicaid reimbursement coverage for telemedicine services, reciprocal licenses for out-of-state providers and the ability to prescribe without an in-person evaluation.

Parity Laws in New York and Connecticut

Effective January 1, 2016, New York passed a Chapter Amendment clarifying last year’s telemedicine commercial coverage statute. Under the 2016 Chapter Amendment, private insurers are required to cover services via telemedicine if provided by hospitals, home care and hospice agencies, licensed physicians, physician assistants, dentists, nurses, midwives, podiatrists, optometrists, ophthalmic dispensers, psychologists, social workers, speech language pathologists and audiologists. The parity law prohibits an insurer from excluding from coverage a service provided via telehealth if that service is otherwise covered in-person.

The law also provides for Medicaid reimbursement to providers for telehealth services, which is defined broadly to include real-time two-way electronic audio visual communications, asynchronous store and forward technology and remote patient monitoring. However, with the exception of remote patient monitoring, telehealth will not be reimbursed by Medicaid when the patient is located in their home. The New York Department of Health is expected to release telemedicine regulations later this year.

Similarly, Connecticut also recently passed a new telemedicine parity law that went into effect January 1, 2016. Under Connecticut’s parity law, commercial insurers must provide coverage for services rendered via telemedicine under the same terms and conditions as would apply if that service was provided in-person. Connecticut broadly defines telehealth to include services performed by a telehealth provider at a distant site as well as synchronous interactions, asynchronous store and forward transfers and remote patient monitoring.

Notably, Connecticut went even farther than New York in its telehealth parity law by expressly preventing a health plan from excluding a service from coverage solely because the service is provided through telehealth and not in-person. In this way, a health plan cannot exclude a telehealth service, such as remote patient monitoring, simply because it does not lend itself to an in-person professional service.

Florida’s Controlled Substance Teleprescription Law

Florida recently implemented a new rule to permit physicians to prescribe controlled substances via telemedicine exclusively for the treatment of psychiatric disorders, effective March 4, 2016. Specifically, the amended regulation provides that controlled substances may not be prescribed through the use of telemedicine, “except for the treatment of psychiatric disorders.”

However, after passing this new rule, the Florida Board of Medicine recognized that it is still restricted by the Federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The Ryan Haight Act narrowly permits the remote prescription of controlled substances for patients without an in-person evaluation so long as the patient is: (1) physically located in a hospital or clinic with a valid DEA registration; and (2) treated by a DEA registered practitioner in the usual course of professional practice and in accordance with state law. Accordingly, while Florida is expanding its telemedicine laws, the prescription of controlled substances via telemedicine will only be broadly permissible if the American Telemedicine Association, or other organizations, are successful in amending the Ryan Haight Act.

Newly Introduced Telemedicine Bills in New Jersey and Ohio

Various other states are also in the process of trying to pass telemedicine bills. For example, New Jersey recently introduced a bill on February 8, 2016, that would require private payors to provide coverage for telemedicine to the same extent that the services would be covered if they were provided through an in-person consultation.

Additionally, another NJ telemedicine bill was introduced on January 12, 2016, which would provide a mechanism for physicians and other health care providers to obtain reciprocal licenses to practice in New Jersey if the providers are licensed by another state in their particular specialty. The bill would also provide a parity law for telemedicine services to be reimbursed under NJ Medicaid. As a similar bill was proposed in 2015 and has now carried over into the 2016 session, the likelihood of its passing is even greater.

An Ohio legislative bill is also headed to the Senate that would allow patients to obtain prescriptions (for non-controlled substances) without an in-person exam or visit from a health care provider.

For more information on telehealth and telemedicine legal and regulatory considerations, continued legislative developments or related issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

This past July, the Federal Communications Commission (“FCC”) released a ruling (the “Ruling”) interpreting the Telephone Consumer Protection Act (“TPCA”) restrictions on certain communications to wireless telephone numbers. The Ruling significantly restricts business’ ability to use auto-dialers and artificial / prerecorded voices for contacting wireless telephone numbers, including via text message (“automated contact system ”), prior to obtaining customer consent. Fortunately for the many health care providers who rely on this type of technology for important patient correspondence such as appointment reminders, the FCC has provided a significant exception for providers’ automated contact systems that meet certain criteria set forth in the Ruling. While the criteria are not overly burdensome, they are numerous and specific, so health care providers with automated contact systems should review them carefully to ensure ongoing compliance with the TPCA.

Following the Ruling, health care providers with automated contact systems must either obtain patient consent prior to using automated contact systems, or be sure that their automated contact system comply with the Ruling. Generally, to be exempt from obtaining prior express consent from patients calls to wireless numbers using automated contact systems:

must not be charged to patient-recipients;

must be for specific, health-related purposes;

must include easy opt-out options; and

are subject to volume and brevity restrictions.

The Ruling describes in greater detail the steps that health care providers must take to meet the above standards.

The FCC ruling is available here. Contact a member of the Benesch team if you have any questions about your automatic contact system after the FCC’s recent ruling.

On April 16, 2015, President Barack Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 and thereby repealed the sustainable growth rate (“SGR”) Medicare Part B provider reimbursement methodology, represented by the Physician Fee Schedule that had been in place for nearly twenty years. SGR reimbursement was originally intended to control Medicare costs by keeping provider reimbursement proportionate to America’s overall economic growth. This was to be accomplished by setting reimbursement ceilings and then cutting reimbursement when those ceilings were exceeded in a given year. Historically, rather than instituting these cuts as planned, Congress repeatedly delayed the implementation of reimbursement reductions through the use of repeated short term legislative patches delaying any cutbacks

This pattern of emergency stop-gap measures ended on April 16, 2015 when, in an uncharacteristically bipartisan move, Congress permanently repealed and replaced the SGR. This revised reimbursement formula includes:

eliminating delayed reimbursement rate reductions under the SGR;

from 2015 – 19, increasing reimbursement rates by 0.5%;

from 2020 – 25, freezing reimbursement rates; and

from 2026 – forward, instituting annual reimbursement rate increases based upon provider participation in one of two provider risk-sharing arrangements: (1) the Merit-Based Incentive Payment System (“MIPS”) provides for a 0.25% annual increase; or (2) Alternative Payment Models (“AMP”) provides for a 0.75% annual increase.

The SGR repeal is funded by reductions in Medicare payments to hospitals and post-acute care providers, elimination of first-dollar Medigap coverage, and increases to Medicare premium cost-sharing for high income beneficiaries. Despite these cuts, the Congressional Budget Office estimates that the legislation will still add a grand total of $141 billion to the Federal deficit.

The elimination of the SGR provides some enduring stability following years of uncertainty. After repeated, temporary SGR legislative fixes, the legislation eliminating the SGR and instituting the replacement reimbursement methodology represents a bipartisan effort to transition Federal health care program reimbursement away from traditional fee-for-service arrangements and into a new era of value-based payments. Consistent with trends in the health care industry at-large, and the Federal health care programs in particular, providers seeking meaningful reimbursement increases through Medicare Part B under the revised reimbursement methodology must meet quality metrics, whether through an incentivized fee-for-service model or through participation in alternative payment mechanisms.

For more information on health care reimbursement trends, please contact a member of Benesch’s health care team.

The Affordable Care Act includes many provisions aimed at improving the quality of care provided by different types of health care professionals and providers. Along these lines, the ACA expands the types of facilities and providers for which quality data will be publically available. The Secretary of the United States Department of Health and Human Services was therefore directed to develop a Hospital Compare website (amongst other similar sites such as Physician Compare and Nursing Home Compare) that would allow Medicare enrollees to compare scientifically sound measures of physician quality and patient experience.

In accordance with these directives, on April 16, 2015 the Centers for Medicare and Medicaid Services (“CMS”) released the first ever Hospital Compare Star Ratings on its public information website. The site is intended to make it easier for consumers to choose a hospital and understand the quality of care they deliver. The data set from the website contains hospital-specific quality data for over 4,500 hospitals nationwide. The ratings are based on the 11 publicly reported measures in the Hospital Consumer Assessment of Healthcare Providers and Systems (“HCAHPS”) survey, which assesses patient experiences.

The star ratings allow for an easy comparison using a five-star scale, with more stars indicating better quality care. The quality data on Hospital Compare includes clinical process of care, patient outcomes and patient experience of care measures. The national rankings are based on hospitals’ performance on the clinical process of care measures and a national survey of patients’ experience of care. The hospitals’ ranks are combined into an overall, composite performance ranking, with process of care measures contributing 70% and patient experience of care measuring 30%.

However, just 251 out of 3,553 hospitals received the highest score in the rating system based on the experiences of patients who were admitted between July 2013 and June 2014. Hospitals had an opportunity to preview the ratings in the fall and many have already expressed concern. Hospitals question the methodology and whether the ratings reflect meaningful reflections of performance. They also assert that the ratings are oversimplifying the hospital’s performance to a single score.

Notably, the patient experience star ratings are only based on the information on quality of care that is reported by patients. The surveys are provided to a random sampling of patients within two days after discharge from a hospital and must be completed within 42 days. Further, positive results may mean that the hospital is delivering good care. However, these results are not taking into account other factors such as timely and efficient care and results or outcomes of care measures. Moreover, the results places substantial reliance on patient review, which is just one measurement of hospital quality. Lastly, if one does not review Hospital Compare extensively, information aside from the star ratings may easily be overlooked. For example, the complete results for each HCAHPS measure can be found in the “Survey of Patients’ experiences” section.

On the other hand, supporters of Hospital Compare argue that while it’s not a perfect measurement system, it creates a healthy competition among hospitals.

For more information on Hospital Compare, other CMS initiatives or related issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

The Centers for Medicare and Medicaid Services (“CMS”) recently released the civil money penalty (“CMP”) analytic tool used by CMS Regional Offices (“RO”) to review, approve or modify the proposed fines for nursing facilities (“NF”) and skilled nursing facilities (“SNF”)(collectively “NF”) (Link). Regulatory guidance CMS S&C 15-16-NH was released on December 19, 2014 and includes a description and the components of the analytic tool used by CMS since April, 2013 to determine the adequacy of the proposed CMPs for survey violations for NFs. The RO is required to review and either approve or modify the proposed CMPs issued by each State Agency based upon NF Medicare and Medicaid certification citations. Providers have often wondered about the actual calculation method being utilized by CMS and this analytic tool lays out the interpretation factors being used by CMS when applying the factors in the required by 42 CFR 488.404 for consideration when imposing a CMP on a facility as result of a single survey or for multiple surveys in a survey cycle.

CMPs and other enforcement remedies are required to be imposed based upon the scope and severity of the regulatory citations either for health deficiencies or life safety code deficiencies. CMS indicates that the analytic tool does not replace professional judgment but it to be used as a guideline in the CMP calculation process. The guidance states that the tool is “provide logic, structure, and defined factors for mandatory consideration in the determination of CMPs.” The analytic tool distinguishes between the use of Per Instance penalty use and a Per Day penalty use. A Per Instance penalty is a single defined fine amount between $1,000 and $10,000 for the survey cycle. The analytic tool indicates that a Per Day penalty is to be used unless the specific requirements are met for the Per Day penalty. A Per Instance penalty is often less costly to a provider than a Per Day penalty and is typically preferred by providers due to the certainty of the actual amount being imposed.

Per Instance penalties can only be applied if:
1. The facility is not a special focus facility;
2. Findings are no more than a G level (actual harm, isolated) or an F level (no actual harm, widespread with substandard care) and the facility has a good compliance history for the past 3 standard surveys; and
3. Findings of past noncompliance are not cited at a G level or an F level substandard care.

In addressing the discretion and professional judgment to be used by the RO personnel the guidance provides for a 35% increase or decrease in the CMP amount without CMS Central Office approval. If the RO proposes to increase or decrease the CMP amount by more than 35%, Central Office must provide approval of those changes. The stated purpose of the utilization of the analytic tool is to provide a more consistent application of enforcement remedies. The guidance also states that a Per Day CMP is to begin on the first day of noncompliance which may or may not be during the on-site survey. Also, the Per Day CMP is to start on the first day of identified noncompliance even if that date is prior to the survey. However, the CMP start date cannot be prior to the date of the last standard survey. This guidance reaffirms the imposition of CMPs that are applied retrospectively with a possibility that CMPs may be imposed as far back as 15 months. A retrospective CMP imposition can be in the hundreds of thousands of dollars for providers for an immediate jeopardy citation and can result in significant ramifications for providers.

A few of the factors that change the proposed amount of CMPs and are calculated with the tool include:
1. Scope and severity of the citations;
2. Number of citations;
3. Repeated citations;
4. Facility culpability; and
5. Facility financial condition.

The guidance provides some examples related to application of criteria for facility culpability based upon Departmental Appeals Board (“DAB”) cases. Those examples include repeated failure to follow or clarify doctor’s treatment orders; repeated failure to notify doctor of significant changes; repeated failure to supervise resident with a known history of elopement; staff failure to report physical, verbal or sexual abuse and egregious dignity issues.

Providers should carefully review this recently issued S&C guidance to have a clear understanding of how the CMPs are calculated by CMS and what factors can affect the increase or decrease of those CMPs. Understanding the factors related to fines and sanctions imposed by CMS and the amount of discretion that is allowed in the imposition of fines are important in the operation of NFs on an ongoing basis.

Palliative care services are now more accessible to patients with serious and chronic illnesses in the United States. The Mayo Clinic defines palliative care as offering pain and symptom management and emotional and spiritual support when a patient faces a chronic, debilitating or life-threatening illness. Increasingly offered to patients of any age with a range of chronic illnesses such as cancer, multiple sclerosis and Parkinson’s disease, palliative care may be provided at the same time as curative medical regimens to help patients tolerate side effects of disease and treatment, and proceed with everyday life. According to a recent December 22, 2014 Wall Street Journal article, palliative care programs have increased three fold over the past decade. Many hospitals have specialized palliative care programs and 80% of hospitals with 250 beds or more provide such a program.

The provision of palliative care with or without curative treatment can lead increased patient and health care provider satisfaction, equal or better symptom control, less anxiety and depression, less caregiver distress, and potential cost savings. A patient’s quality of life can be enhanced with active and effective pain and symptom management. The need for aggressive pain and symptom management often lead patients to seek out a palliative care program to manage their symptoms during a chronic or terminal illness. Some patients also choose to utilize hospice care towards the end of their life journey after receiving services from a palliative care program. With the better availability of palliative care, those patients seeking pain relief and symptom control at any stage of their chronic or terminal illness care are able to find the services to address their needs including assisting the patient and the family to navigate the often complicated medical system.

May a licensed healthcare professional refuse to treat a patient? Healthcare providers have legal, ethical and professional duties to address a patient’s needs that fall within the provider’s scope of practice. However, are doctors, and other health care personnel, required to treat any and all patients, even if doing so might cost them their lives? While this is an issue that has arisen with the recent Ebola outbreak, it is not a new issue and has been previously addressed.

History of Refusing to Treat

During the early HIV/AIDS era in the 1980s, when there was little known about the disease, there were physicians and other health care workers who refused to treat HIV infected patients. Accordingly, in 1992, the American Medical Association declared in an ethics opinion that “A physician may not ethically refuse to treat a patient whose condition is within the physician’s current realm of competence solely because the patient is seropositive for HIV. Persons who are seropositive should not be subjected to discrimination based on fear or prejudice.” AMA Opinion 9.131 (March 1992, updated June 1996 and June 1998).

Similarly, the American Dental Association stated in its Principles of Ethics and Code of Professional Conduct that, “[a] dentist has a general obligation to provide care to those in need. A decision not to provide treatment to an individual because the individual has AIDS or is HIV seropositive based solely on that fact is unethical.” American Dental Association, ADA Principles of Ethics and Code of Professional Conduct III § 4.A.1 (2012).

During the recent Ebola outbreak, healthcare personnel were once again refusing to treat infected patients. Is this acceptable?

EMTALA

The Emergency Medical Treatment and Labor Act (“EMTALA”) is a federal law that requires that any patients that present at an emergency department must be stabilized and treated in a non-discriminatory manner, regardless of their insurance status, ability to pay, national origin, race, creed or color. 42 U.S.C. § 1395dd. Hospitals may not transfer or discharge patients needing emergency treatment except with the informed consent (itself a legal doctrine) or stabilization of the patient, or when their condition requires transfer to a hospital better equipped to administer the treatment.

Since Ebola qualifies as an emergency medical condition, patients with the disease would fall under EMTALA. SeeCMS Bulletin (November 21, 2014). Upon arrival at the emergency department, even if Ebola is suspected, EMTALA would require the patient be medically screened and treated until the emergency condition is resolved or stabilized. Hospitals lacking the ability to provide care to such patients may transfer the patients to another facility under strict transfer guidelines. Both individual providers and hospitals have a legal obligation to comply with EMTALA. If found in violation of the act, hospitals and healthcare providers may lose their Medicare provider agreement and be fined up to $50,000 per violation as well as be subject to any lawsuits that may arise.

Pre-existing or Contractual Relationships

Aside from EMTALA which governs treatment of patients in emergent situations within emergency facilities, U.S. law generally allows healthcare providers to accept or decline patients at will. There are a few exceptions to this rule. First, many hospital medical staff bylaws, state medical board licensing and discipline requirements and contractual arrangements require physicians to comply with American Medical Association ethics guidelines. These ethics guidelines may well require a physician to provide care to an Ebola patient, such as the AMA opinion cited above. Additionally, managed care agreements may also require an assessment of the patient.

A second exception concerns a prior-existing provider-patient relationship. Breaking this relationship without transferring care to another provider constitutes “abandonment.” For example a patient with whom a healthcare professional has previously established a professional relationship may present in the professional’s office with complaints of fever, muscle ache and abdominal pain. That patient may also have a history showing that he or she recently travelled to an Ebola hot spot or area with a high risk of Ebola. As with any other patient, the provider must provide treatment and/or refer them to another source for treatment. Otherwise, the healthcare professional is at risk for abandonment of the patient.

However, if a patient with whom the healthcare professional has no pre-existing care relationship presents in the professional’s office with the above-described complaints, and there is no other duty under any other basis (i.e. not an ER physician, or in any other way obligated to treat the patient), then the question becomes is the healthcare professional qualified to treat the patient. In most situations, the professional typically has the legal right to decide whether to accept the patient or not.

Third, the American with Disabilities Act of 1991 prohibits providers from refusing care to patients on the basis of disability.

Lastly, states may have their own laws outlining when providers can and cannot refuse to treat certain patients. For example, the Rhode Island Department of Health recently released a statement providing that, “In Rhode Island, licensed healthcare professionals in active practice are obligated to treat and/or care for Ebola patients, while minimizing the risk of Ebola transmission to self and others.” The statement notes that failure to comply is a potential breach of the state’s healthcare licensing laws and could result in sanctions.

Personal Safety

Healthcare providers also operate along ethical principles concerning their duty to treat. The general guideline acts to ensure that the provider does not feel threatened for his or her personal safety. In fact, the preparedness protocols that were designed by the Centers for Disease Control and Prevention (“CDC”) presents a mission to care for those in need, but has an underlying theme of safety as the number one priority. The protocols emphasize that all healthcare workers involved in the care of Ebola patients: (i) must have received repeated training and demonstrated competency in performing all Ebola-related infection control practices and procedures; (ii) should have no skin exposed; and (iii) must have an onsite manager at all times overseeing the safe care of Ebola patients in a facility. Notably, the CDC has also stated that the risk of transmission of Ebola, in and of itself, does not provide a basis for the relaxation of a health professional’s duty to help a patient as the risk of disease transmission is understood and can be readily mitigated.

Ultimately, the decision to treat an Ebola patient is fact dependent, based on the overall safety of the healthcare professional. For example, a healthcare worker may be situated in a rural area without proper equipment and without any safety mechanisms in place. If the professional is confronted with a patient diagnosed with Ebola and in the active stages of the disease, the ethical concerns may be trumped by treatment concerns. Similarly, a leading medical ethicist, Dr. Joseph J. Fins, has stated that a medical team should not try to resuscitate an Ebola patient whose heart has stopped beating. Dr. Finns explained that the risks of cardiopulmonary resuscitation efforts are too great for health care workers and even for some Ebola patients whose heartbeat is restored.

On the other hand, a healthcare professional may work in a health system that is ripe with safety protocols and mechanisms available. If that professional is confronted with a patient diagnosed with Ebola, the concern for personal safety may not outweigh the ethical duty to treat. Ultimately, it will be a decision for the healthcare professional to make concerning his or her personal safety.

National Guidelines

Conflicting laws, ethical guidelines and varying circumstances have created great uncertainty about the duty to treat. In fact, the decision whether the duty to treat trumps safety concerns has sparked a thorny debate at hospitals across the country along with a call for national guidelines. See U.S. Hospitals Weigh Staff Safety, WSJ (October 31, 2014).

For more information on legal concerns in the treatment of Ebola or related clinical legal issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

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